Title:  Senior Associate, Quality Compliance

Sun Pharma is the world’s fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology. 

Job Summary:
The Quality Assurance Specialist is responsible for the batch certification review of site QA activities related to manufacturing and packaging records, as well as all supporting documentation. This includes ensuring compliance with Standard Operating Procedures (SOPs), equipment and instrument maintenance, calibration, qualification, and validation in accordance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and ALCOA++ principles. The role also provides support during regulatory, corporate, and internal audits.

Key Responsibilities

• Support batch certification activities for commercial distribution in the USA and Canada, ensuring timely execution aligned with production schedules and deliverables.
• Serve as a subject matter expert in sterile manufacturing and packaging processes.
• Review investigations related to site incidents and deviations (planned/unplanned, FARs), ensuring corrective and preventive actions are appropriate and effective.
• Ensure compliance with regulatory requirements for product, process, equipment, and release procedures.
• Provide support during regulatory audits, internal and external inspections, and corporate audits. Responsible for follow-up on operational findings from FDA and other regulatory bodies.
• Participate in and conduct mock inspections to prepare the facility for audits; assess system gaps and review documentation for compliance with current regulations and cGMP standards.
• Identify compliance issues and support implementation of continuous improvement initiatives.
• Promote adherence to SOPs and policies, ensuring procedures reflect current practices.
• Perform additional assignments as required.

Work Conditions

• Corporate office environment
• Manufacturing and production areas
• Laboratory settings
• Warehouse environment
• Field familiarity as needed

Physical Requirements

• Ability to bend, lift, move, and carry items up to approximately 10 pounds.
• Capable of navigating office, lab, and plant floor environments; standing, walking, and reaching as needed.
• Must be able to wear required personal protective equipment (PPE), including respirators, safety glasses/goggles, and safety shoes.

Travel Requirements

• Up to 30%

Qualifications

Education:

• Minimum of a Bachelor's degree required.
• Participation in seminars and training courses is considered an asset.

Skills & Competencies:

• Strong understanding of cGMPs, particularly those related to documentation practices.
• Ability to work effectively within an international, multicultural matrix organization.
• Proficiency in software applications including MS Word, Excel, PowerPoint, Outlook, Acrobat Reader, TrackWise, LMS, and other relevant systems.
• Knowledge of project management principles and tools.
• Excellent communication, interpersonal, and organizational skills.

Experience

• Minimum of 7 years of experience in the pharmaceutical industry.
• Experience working in a global, multicultural matrix organization.

The presently-anticipated base compensation pay range for this position is $90,000 to $112,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives:

Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.